NIH funds four clinical trials to fight antimicrobial resistance

Eight large NIH trials now seeking to preserve the usefulness of licensed
antibiotics

The National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health, today announced four new contracts
for large-scale clinical trials that address the problem of antimicrobial
resistance. Over the next five to six years, these new clinical trials
will evaluate treatment alternatives for diseases for which antibiotics
are prescribed most often, including acute otitis media (middle ear infections),
community-acquired pneumonia and diseases caused by Gram-negative bacteria,
which frequently are resistant to first-line antibiotics. Each trial
will enroll at least 1,000 participants who have been diagnosed with
these illnesses and diseases.

“Many infectious diseases are increasingly difficult to treat because
bacteria and other microbes have developed resistance to commonly used
antimicrobial drugs,” says NIAID Director Anthony S. Fauci, M.D. “Research
to preserve the effectiveness of licensed antibiotics is a critical priority
for the Institute. With these new contracts, NIAID now supports a total
of eight large clinical trials in this arena.”

Antimicrobial research has changed significantly since many current
drugs were developed, says Dennis M. Dixon, Ph.D., chief of NIAID’s Bacteriology
and Mycology Branch. “Years ago, we were not as focused on antimicrobial
resistance because there was generally another class of drug in the research
and development pipeline. Today, the development of new antimicrobials
is moving much more slowly than the evolution of resistance to existing
treatments, so we need to preserve the drugs we have.”

These new trials are part of a two-pronged NIAID approach to antimicrobial
research: learning how to make better use of the drugs we have today
in order to protect their usefulness while simultaneously facilitating
the development of new drugs.

Like the four large NIAID trials already in progress, the four new studies
are designed to answer specific questions about how to improve treatment
strategies. The investigators will conduct clinical trials of new regimens
involving the use of already licensed, off-patent antimicrobial therapies
to reduce the risk of antimicrobial resistance developing in the diseases
of interest. For example, the dosage and duration of treatment will be
evaluated.

“If one type of treatment proves to be just as safe and just as effective
as one that is traditionally used, but less likely to induce antimicrobial
resistance, then the new treatment could be preserved for a longer time,” says
Dr. Dixon. “These clinical trials look not only at effectiveness of various
antimicrobial drugs in the individual patient, but also at how to preserve
the most effective use of drugs in the overall population. The goal is
to be more precise with what antimicrobial drugs a patient needs, at
what dose, and for how long.”

NIAID conducts and supports research—at NIH, throughout the United
States, and worldwide to study the causes of infectious and immune-mediated
diseases, and to develop better means of preventing, diagnosing and treating
these illnesses. News releases, fact sheets and other NIAID-related materials
are available on the NIAID Web site at http://www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services. NIH
is the primary federal agency conducting and supporting basic, clinical, and
translational medical research, and is investigating the causes, treatments,
and cures for both common and rare diseases. For more information about NIH
and its programs, visit http://www.nih.gov.